PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00763000284633), received between Nov 30, 2021 and Jan 27, 2026 — classified as 1 death, 2 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (30 reports).

12 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER MEASUREMENT, THE SURGEON PLANNED TO ANCHOR THE DISTAL END OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT AT THE DISTAL INTERNAL CAROTID ARTERY AND PLACE THE PROXIMAL END OF THE STENT IN THE STRAIGHT SEGMENT OF THE CAVERNOUS SINUS. DURING THE PROCEDURE, THE SURGEON PLACED A 6F NAVIEN CATHETER IN THE POST-CAVERNOUS ASCENDING SEGMENT AND A PHENOM 27 MICROCATHETER IN THE M2 SEGMENT. AFTER THOROUGH HYDRATION, THE PIPELINE STENT WAS DELIVERED. DURING DELIVERY, THE SURGEON REPORTED INCREASING RESISTANCE MID-CATHETER. WHEN THE STENT REACHED THE OPHTHALMIC ARTERY CURVE, THE RESISTANCE WAS SIGNIFICANT. THE SURGEON INCREASED THE TENSION ON THE DELIVERY ROD AND CONTINUED ADVANCING THE STENT. AFTER DELIVERING THE STENT TO THE STRAIGHT SEGMENT OF M1, THE SYSTEM TENSION WAS ADJUSTED. THE STENT WAS FIXED, AND THE MICROCATHETER WAS RETRACTED, EXPOSING APPROXIMATELY 5 MM OF THE STENT. THE DISTAL END OF THE STENT DID NOT OPEN. THE SURGEON PUSHED THE STENT TO INCREASE TENSION, BUT IT STILL DID NOT OPEN. THE SURGEON CONTINUED DEPLOYING APPROXIMATELY 8 MM OF THE STENT, BUT IT REMAINED UNOPENED. CONSIDERING THAT THE LARGE-SIZED STENT MIGHT BE OBSTRUCTED FROM OPEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192938 ↗
• MalfunctionJan 20, 2026Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2-475-20) WAS OPENED, BUT IT COULD NOT BE DEPLOYED. MULTIPLE ATTEMPTS WERE MADE BUT THE STENT STILL COULD NOT BE DEPLOYED, AND UPON REMOVAL, THE TIP END WAS FOUND TO BE FRAYED. THE STENT WAS REPLACED WITH A PED2-450-25 STENT, WHICH ENCOUNTERED THE SAME ISSUE. THE SURGICAL PLAN WAS SUBSEQUENTLY CHANGED TO STENT-ASSISTED COIL EMBOLIZATION USING A NON-MEDTRONIC PRODUCT, TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS INITIALLY UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT INTERNAL CAROTID ARTERY, OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.7 MM DISTALLY AND 4.54 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED RIGHT INTERNAL CAROTID ARTERY, OPHTHALMIC ARTERY SEGMENT ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118344 ↗
• MalfunctionJan 15, 2026Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED EFT INTERNAL CAROTID ARTERY, C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 16 MM AND A 7 MM NECK DIAMETER. THE LANDING ZONE WAS 4.1MM DISTALLY AND 4.8MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS RIGHT FEMORAL ARTERY, WITH 5.1MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NOT PERFORMED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT THE PIPELINE SHIELD IMPLANTATION WAS UNSUCCESSFUL. IT WAS REPORTED THAT AFTER ADEQUATE HYDRATION, THE PHENOM27 REACHED THE M2 SEGMENT; THE SHIELD WAS ADEQUATELY HYDRATED AND DELIVERY WAS INITIATED. RESISTANCE WAS ENCOUNTERED WHEN DELIVERING TO THE PROXIMAL END OF THE MICROCATHETER, MAKING NORMAL DELIVERY IMPOSSIBLE, BUT THE PED STENT DID NOT STUCK IN THE CATHETER. THE OPERATOR WAS AWARE THAT THE PIPELINE STENT COULD NOT BE FULLY RETRIEVED INTO THE INTRODUCER SHEATH AFTER BEING PUSHED INTO THE MICROCATHETER. HE ATTEMPTED TO RETRIEVE THE STENT INTO THE INTRODUCER SHEATH TO CONTINUE USING IT, BUT THE ATTEMPT WAS UNSUCCESSFUL. THE STENT COULD NOT BE SUCCESSFULLY IMPLANTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080132 ↗
• MalfunctionJan 6, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED C6 OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 2.73MM AND A 3.2MM NECK DIAMETER. THE LANDING ZONE WAS 6MM DISTALLY AND 13MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH AN 8MM DIAMETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU VALUE WAS WITHIN THE ACCEPTABLE RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE ANEURYSM WAS LOCATED IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY, AND THE BLOOD VESSEL WAS QUITE TORTUOUS. IT WAS REPORTED THAT A TONGQIAO XUANWU GUIDING CATHETER SHEATH WAS USED AS THE LONG SHEATH, A MINIMALLY INVASIVE 6F U-TRACK WAS USED AS THE INTRACRANIAL SUPPORT CATHETER, A PHENOM27 MICROCATHETER WAS SELECTED, AND THE FLOW DIVERTER STENT MODEL WAS PED2-475-25. DURING THE DEPLOYMENT OF THE FLOW DIVERTER STENT, THE TIP FAILED TO OPEN AFTER MULTIPLE ATTEMPTS. UPON WITHDRAWAL, BURRS WERE FOUND ON THE TIP. CONSIDERING THE PATIENT'S SAFETY AND THE STABILITY OF THE DELIVERY SYSTEM, THE MICROCATHETER W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973170 ↗
• MalfunctionNov 14, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON 10 MICROCATHETER WAS KINKED/BROKEN AT THE DISTAL END, RESISTANCE WAS ENCOUNTERED IN THE MIDDLE OF A MARKSMAN CATHETER, TWO PIPELINE FLEX WITH SHIELD TECHNOLOGY FLOW DIVERSION STENTS FAILED TO OPEN, AND AN AXIUM PRIME BARE COIL REQUIRED ADJUNCTIVE STENT PLACEMENT TO RETAIN IT WITHIN THE ANEURYSM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION ASSISTED EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM AT THE RIGHT MIDDLE CEREBRAL ARTERY M1 SEGMENT COMBINED WITH AN ANEURYSM AT THE RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT, WITH A MAX DIAMETER OF 3.6 MM AND A 3.2 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.3 MM DISTALLY AND 4.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. RIGHT FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 7 MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS 2. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED AN ANEURYSM AT THE RIGHT MIDDLE CEREBRAL ARTERY M1 SEGMENT COMBINED WITH AN ANEURYSM AT THE RIGHT INTERNAL CAROTID ARTERY C6 SEG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556957 ↗
• InjuryOct 31, 2025Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AMORPHOUS, UNRUPTURED C6 SEGMENT ANEURYSM OF INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.2 MM AND A 2.5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.6MM DISTALLY AND 4.7MM PROXIMALLY. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WITH 7.5MM DIAMETER. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT WHEN THE SURGEON WAS DEPLOYING THE MESH STENT (PED2-475-20), THE STENT TIP WAS DIFFICULT TO OPEN AT DISTAL SECTION. AFTER PATIENT OPERATION, THE TIP WAS PARTIALLY OPENED, BUT THE SHAPE OF THE STENT TIP WAS NOT GOOD. THE STENT TIP WAS FRIZZY AS SEEN ON THE IMAGING. EVEN AFTER INCREASING AND DECREASING TENSION AND DEPLOYING A RELATIVELY LONG SECTION OF THE STENT UNDER STANDARD OPERATING PROCEDURES, AND THEN RETRIEVING IT ONCE, THE STENT STILL FAILED TO OPEN PROPERLY AND HAD A ROUGH TIP. FURTHERMORE, THERE WAS INCREASED RESISTANCE AT MIDDLE SECTION F THE PHENOM CATHETER DURING SUBSEQUENT STENT PUSHING. THE SURGEON DETERMINED THAT THE STENT AND CATHETER WERE DAMAGED AND SHOULD NOT BE USED FURTHER. A PED2-450-18 AND THE SAME TYPE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439657 ↗
• MalfunctionOct 15, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING DENSE MESH STENT-ASSISTED TREATMENT FOR AN ANEURYSM, A PHENOM 27 WAS USED TO DELIVER THE 475-20 STENT. AFTER THE STENT WAS POSITIONED, DEPLOYMENT WAS INITIATED, BUT THE TIP END OF THE STENT REMAINED ROD-SHAPED AND COULD NOT BE OPENED DESPITE MULTIPLE ATTEMPTS. AFTER REMOVING THE SYSTEM, THE STENT¿S TIP END WAS FRAYED, AND THE TIP OF THE PHENOM 27 MICROCATHETER WAS KINKED. THE SYSTEM WAS THEN REPLACED WITH A NEW ONE (PHENOM 27 AND PED2 500-20), AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR DENSE MESH STENT TREATMENT OF A SACCULAR, UNRUPTURED CAVERNOUS SINUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 7.9MM AND A 4.9MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.8MM AND PROXIMAL: 4.75MM. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A 6.0MM DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD VESSEL PATENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300567 ↗
• MalfunctionAug 18, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, AND NO SEGMENT OF THE DEVICE WAS POSITIONED IN A BEND. NO ADDITIONAL STEPS OR DEVICES, SUCH AS RESHEATHING, WIRE, CATHETER, OR BALLOON, WERE ATTEMPTED, AND THE DEVICE WAS NOT RESHEATHED. FOLLOWING THE FAILURE TO OPEN, THE SECOND PIPELINE (PED2-500-20, D044999) WAS ALSO CONFIRMED TO BE DAMAGED. THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833419 ↗
• MalfunctionJul 17, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE OPENING FAILURE WAS UNDETERMINED. NO SIGNIFICANT FRICTION OR DIFFICULTY WAS FOUND DURING DELIVERY OR RETRIEVAL. IT WAS UNKNOWN IF THERE WAS ANY ALLEGATION AGAINST THE PHENOM CATHETER. THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE DEVICE WAS RETRIEVED INTO A MICROCATHETER AND DEPLOYED; NO ADDITIONAL DEVICES (RESHEATHING, WIRE/CATHETER, OR BALLOON) WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530570 ↗
• MalfunctionJul 2, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS XXX AND VESSEL TORTUOSITY WAS MINIMAL. THE LANDING ZONE WAS 4.7MM DISTALLY AND 4.9MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT AN INTRACRANIAL ANEURYSM EMBOLIZATION WAS PERFORMED USING A BLOOD FLOW DIVERSION DENSE MESH STENT. AFTER THE C ATHETER WAS IN PLACE, THE BLOOD VESSEL DIAMETER WAS MEASURED AND THE PED2-475-20 STENT WAS SELECTED. THE TIP OF THE STENT COULD NOT BE OPENED, AND EVEN AFTER MULTIPLE ATTEMPTS, IT STILL COULD NOT BE OPENED. THE STENT WAS THEN WITHDRAWN AND REPLACED IT WITH ANOTHER MODEL OF STENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD RETENTION IN ANEURYSM. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386883 ↗
• MalfunctionApr 30, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD STENT THAT WAS KINKED AND FAILED TO OPEN IN THE MIDDLE SEGMENT. THE PATIENT WITH MULTIPLE ANEURYSMS WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT IN THE C6-C7 SEGMENTS. THE MAX ANEURYSM DIAMETER WAS 3MM WITH A NECK DIAMETER OF 2MM. THE DISTAL LANDING ZONE WAS 4MM; THE PROXIMAL LANDING ZONE WAS 4.9MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE MICROCATHETER WAS IN PLACE, PIPELINE DEPLOYMENT WAS INITIATED. THE TIP OF THE PIPELINE STENT WAS OPENED BUT AS DEPLOYMENT CONTINUED, A KINK APPEARED IN MIDDLE SEGMENT OF THE PIPELINE STENT. THE DEVICE WAS RETRACTED AND REDEPLOYED AND PUSH/PULL WAS TRIED, BUT THE STENT COULD NOT BE OPENED SO IT WAS REMOVED FROM THE PATIENT AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934461 ↗
• MalfunctionFeb 20, 2025Unintended Ejection; Retraction Problem; Physical Resistance/Sticking; Unintended Ejection; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY REPLACING THE STENT. PREMATURE DEPLOYMENT OCCURRED I NTRAOPERATIVELY. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE. THE CAUSE OF THE RETRIEVAL FAILURE/DETACHMENT WAS NOT DETERMINED. RESISTANCE DURING RETRIEVAL OCCURRED IN THE PROXIMAL END OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420926 ↗
• MalfunctionFeb 18, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING THE TREATMENT OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH FUSIFORM MORPHOLOGY USING A PIPELINE EMBOLIZATION DEVICE 4.75MM X 20MM, THE CATHETER COULD NOT BE DEPLOYED AFTER TWO ADJUSTMENTS DURING THE IMPLANTATION PROCESS. THE ANEURYSM WAS UNRUPTURED WITH A MAXIMUM DIAMETER OF 4 MILLIMETERS AND A NECK DIAMETER OF 3 MILLIMETERS. THE DISTAL LANDING ZONE WAS 10 MILLIMETERS, AND THE PROXIMAL LANDING ZONE WAS 12 MILLIMETERS, WITH NORMAL VESSEL TORTUOSITY. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNIT LEVEL WAS 0. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS NORMAL. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE: STRYKER GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403580 ↗
• MalfunctionFeb 10, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE FAILURE TO OPEN WAS DIFFICULT TO JUDGE, BUT THE OVERALL FEELING WAS THAT IT WOULD BE DIFFICULT TO OPEN THE STENT OF RELATIVELY LARGE MODEL. IT COULD NOT BE DETERMINED IF THERE IS AN ISSUE WITH THE PHENOM CATHETER. DIDN'T KNOW IF THERE WAS THE PROBLEM WITH THE INTERNAL CATHETER LUMEN, THE MAIN REASON WAS THAT IT COULDN'T BE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349201 ↗
• MalfunctionFeb 5, 2025Unintended Ejection; Activation, Positioning or Separation Problem; Unintended Movement; Activation Failure; Unintended Ejection; Activation, Positioning or Separation Problem; Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PREMATURE DEPLOYMENT OCCURED WHEN ATTEMPTING TO RESHEATH THE DEVICE. THE PUSHWIRE ROTATED OR PULLED BACK IN ORDER TO RESHEATH. THREE "DEVICES" WERE RETURNED. ONE REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318450 ↗
• MalfunctionDec 10, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892779 ↗
• MalfunctionDec 10, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, TWO PIPELINE FLEX WITH SHIELD DEVICES DISPLAYED A "TRUMPETED DISTAL OPENING" AND WERE REMOVED DUE TO FAILURE TO OPEN IN THE DISTAL SECTION. EACH DEVICE WAS RESHEATHED MORE THAN TWO TIMES, AND WERE NOT POSITIONED IN A BEND. ADDITIONALLY, THE BACK HALF OF A PIPELINE VANTAGE DEVICE FAILED TO FULLY OPEN IN THE MIDDLE SECTION, WHICH WAS POSITIONED IN A GENTLE CURVE OF THE CAVERNOUS/PETROUS SECTION OF THE INTERNAL CAROTID ARTERY. THE ANEURYSM WAS LOCATED IN THE LEFT CAVERNOUS/PETROUS SECTION, UNRUPTURED, WITH A SACCULAR MORPHOLOGY, MEASURING 7X12 MILLIMETERS IN DIAMETER WITH A 4-MILLIMETER NECK DIAMETER. THE LANDING ZONE ARTERY SIZE WAS 4 MILLIMETERS BOTH DISTALLY AND PROXIMALLY, AND THE VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ANGIOGRAPHIC RESULT POST-PROCEDURE SHOWED BRISK FLOW THROUGH THE CONSTRUCT WITH NO CUTOFFS OR CLOT MENTIONED. THE DEVICES WERE REMOVED FROM THE PATIENT, RESHEATHED, AND REMOVED WITH THE MICROCATHETER. THE PIPELINE VANTAGE DEVICE WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892737 ↗
• MalfunctionOct 9, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RIGHT C4 ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 7.9 MM, NECK DIAMETER 6.2 MM. LANDING ZONE (ARTERY SIZE): DISTAL 4.5 MM AND PROXIMAL 4.9 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. AFTER ANGIOGRAPHY, THE DIAMETER OF THE NAVIEN TIP WAS CALIBRATED IN 2D AND THE BLOOD VESSELS WERE MEASURED. THE DISTAL DIAMETER OF THE OPHTHALMIC ARTERY AT THE DISTAL ANCHOR POINT WAS 4.5 MM. THE PROXIMAL VESSEL DIAMETER IS 4.9 MM AND THE LENGTH WAS 20 MM, SO A PED-475-20 DENSE MESH STENT WAS SELECTED FOR IMPLANTATION. THE ACCESS ADOPTED 6F-90 LONG SHEATH +5F115NAVIEN, AND THE PHENOM27 STENT CATHETER WAS GUIDED TO M1 SECTION THROUGH THE GUIDE WIRE, AND THE GUIDE WIRE WAS WITHDRAWN. UNPACKED THE STENT AND PERFORMED HIGH-PRESSURE DRIPPING TO HYDRATE UNTIL 10 DROPS OF WATER WERE PRODUCED. PRESSED THE DELIVERY SHEATH AGAINST THE PHENOM27 HUB PORT, THEN DELIVERED THE STENT TO THE M1 SEGMENT, WITH THE STENT TIP EXPOSED ABOUT 7 MM.  UNDER FLUOROSCOPY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409109 ↗
• MalfunctionAug 8, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN USING A DENSE MESH STENT TO TREAT AN ANEURYSM, THE STENT TIP COULD NOT BE OPENED. AFTER MULTIPLE ATTEMPTS, THE STENT STILL COULD NOT BE OPENED. AFTER WITHDRAWING THE SYSTEM AND REPLACING IT WITH A NEW STENT AND CATHETER, THE OPERATION WAS SUCCESSFULLY COMPLETED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR DENSE MESH STENT FOR ANEURYSM TREATMENT OF A SACCULAR, UNRUPTURED C6 ANEURYSM WITH A MAX DIAMETER OF 6.7MM AND A 5.7MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.4MM. THE LANDING ZONE WAS 4.8MM DISTALLY AND 4.7 PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL BLOOD VESSELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939274 ↗
• MalfunctionMay 16, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING DENSE MESH STENT IMPLANTATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT UPPER CLINOID SEGMENT WITH A MAX DIAMETER OF 5.63 MM AND A 4.87 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.87 MM AND PROXIMAL: 4.64 MM. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 3.65 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 0. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT UNDER THE GUIDANCE OF THE NERVE GUIDEWIRE, THE PHENOM27 WAS SMOOTHLY RAISED TO THE MIDDLE CEREBRAL ARTERY. THE PED2 STENT WAS SMOOTHLY RAISED THROUGH THE PHENOM27, AND THE STENT WAS STARTED TO BE RELEASED. RELEASED THE TIP END OF THE STENT IN SITU, THE STENT WAS NOT OPENED AT ALL, RAISED THE MIDDLE CATHETER, WAITED FOR A CERTAIN PERIOD OF TIME, PUSHED AND PULLED THE STENT AND SWUNG THE WHOLE PART, BUT THE TIP END OF THE STENT WAS STILL NOT OPENED. RAISED PHENOM27, AND THEN RETRIEVED THE STENT, AND RELEASED IT AGAIN. AFTER MANY OPERATIONS, THE PROBLEM STILL COULD NOT BE SOLVED. THE TIP E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331091 ↗
• MalfunctionMar 15, 2024Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PROXIMAL SECTION FAILED TO OPEN AND THE RETRIEVAL OF THE DEVICE FAILED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA). LANDING ZONE: DISTAL: 3.98 MM AND PROXIMAL: 4.77 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS WITHIN THE THERAPEUTIC RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A GOOD RESULT. FULL BLOOD FLOW THROUGH THE ICA WITH STASIS IN THE ANEURYSM. PATIENT WOKE UP AND WAS RESPONDING WELL TO COMMANDS. IT WAS REPORTED THAT THE PIPELINE WAS PROPERLY POSITIONED AND BEGAN TO DEPLOY AS INTENDED. ONCE THE PROXIMAL END OF THE PIPELINE WAS PUSHED OUT AND DEPLOYED, A FLATTENING WAS NOTICED NEAR THE PROXIMAL PORTION. THE PHENOM 27 WAS NOT ABLE TO RECAPTION THE DELIVERY WIRE. ATTEMPTS WERE MADE TO RECROSS THE PIPELINE IN ORDER TO POST PROCESS WHICH WERE UNSUCCESSFUL. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914143 ↗
• MalfunctionFeb 26, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE PIPELINE FAILURE MIGHT BE DUE TO THE INFLUENCE OF SMALL WINGS AT THE TIP END. WHEN THE STENT CATHETER WAS RETRIEVING THE STENT, THE TIP END OF THE STENT MIGHT BE PIERCED. THERE ARE NO OTHER OPERATIONS OR EXTRA STEPS DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778484 ↗
• DeathAug 31, 2023No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT PRESENTED WITH A GIANT ANEURYSM. THE PHYSICIAN TREATED IT BY PLACING TWO STRYKER COILS IN THE ANEURYSM AND LAID A PIPELINE SHIELD ACROSS THE NECK OF THE ANEURYSM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN AND PLAVIX. ON (B)(6) 2023 THE PATIENT RETURNED TO THE HOSPITAL IN THE EMERGENCY ROOM WITH A SUBARACHNOID HEMORRHAGE. THE PATIENT WAS BROUGHT TO INTERNAL RADIATION FOR IMAGING AND FOUND TO HAVE RUPTURED THE PREVIOUSLY TREATED ANEURYSM. THE PHYSICIAN THEN PLACED TWO MORE PIPELINE SHIELD DEVICES ACROSS THE NECK OF THE ANEURYSM TO TRY AND STOP THE BLEEDING. ON (B)(6) 2023 THE PATIENT CLOTTED OFF THEIR PARENT VESSEL WHERE THE TWO ADDITIONAL PIPELINES HAD BEEN PLACED. MANY ATTEMPTS WERE MADE TO CLEAR THE CLOT BUT THEY WERE NOT SUCCESSFUL. THE PATIENT PASSED AWAY ON (B)(6) 2023. THE PIPELINES WERE NOT USED FOR AN OFF-LABEL USE. THE PIPELINE DEVICES AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 25MM AND A 10MM NECK DIAMETER. THE L

  Patient problems: Intracranial Hemorrhage; Obstruction/Occlusion; Rupture

  MAUDE report 17664716 ↗
• MalfunctionAug 24, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS ADVANCED INTO DESIRED LOCATION. THE PHYSICIAN BEGAN TO UNSHEATH AND THE DEVICE STRUGGLED TO OPEN DISTAL END. THE PHYSICIAN RE-CAPTURED AND WAGGED THE DEVICE TO TRY AND OPEN, DEPLOYED ABOUT 85% OF DEVICE; HOWEVER IT REFUSED TO OPEN. THE PHYSICIAN DECIDED TO RECAPTURE AND RETRIED WITH A SECOND PIPELINE DEVICE (5 16). THE PIPELINE FAILED TO OPEN IN THE MIDDLE AND DISTAL SECTIONS. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE 2ND DEVICE WAS ADVANCED (PIPELINE 5 16); IT STRUGGLED TO OPEN MID DEVICE BUT EVENTUALLY OPENED; PHYSICIAN PLACED 2ND DEVICE POST BALLOON ANGIOPLASTY, MOVED DEVICE AND UNCOVERED PART OF THE ANEURYSM NECK, PLACED A 2ND DEVICE 5 X 18. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617847 ↗
• MalfunctionApr 4, 2023Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT DURING THE SECOND RESHEATHING OF THE DEVICE, THE DEVICE SLIPPED OFF THE RESEATHING PAD. THE DISTAL 5 MM OF DEVICE REMAINED OPEN OUT OF THE MICROCATHETER WHILE THE WIRE BEGAN TO PULL BACK INTO THE MICROCATHER. THE OPERATOR WAS ABLE TO CORK THE DEVICE AND REMOVE THE MICROCATHETER AND PARTIALLY DEPLOYED DEVICE THROUGH THE NAVIEN AND OUT OF THE PATIENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY  PARA OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 4.3MM AT THE DISTAL END AND 4.8MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NO STASIS, DEVICE APPOSED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676273 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0309-2017 · Oct 5, 2016 · Terminated
  Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-0308-2017 · Oct 5, 2016 · Terminated
  Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
• Z-0307-2017 · Oct 5, 2016 · Terminated
  Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
• Z-0120-2016 · Sep 4, 2015 · Terminated
  -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
• Z-1453-2014 · Apr 1, 2014 · Terminated
  Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
• Z-2045-2013 · Jul 19, 2013 · Terminated
  Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-neck